Quality Assurance Inspector

QUALITY ASSURANCE INSPECTOR

Reports To

FLSA Status

Non-Exempt

Department

Quality Assurance

Location

87 Modular Avenue

Prepared by

Carmen Cunningham

Verified by

Summary

The Quality Assurance Inspector is responsible for GMP compliance throughout all of Gemini's facilities, the receipt and control of incoming components, performing continuous checks at the setup, during, and at the completion of manufacturing and packaging operations according to stated company procedures, FDA regulations, and as instructed by the Quality Assurance Manager.

Essential Duties and Responsibilities:

The following duties are required, with additional responsibilities as assigned:

• Monitor all GMP activities in assigned areas and throughout Gemini facilities.
• Monitor temperature and humidity in all production and warehouse areas throughout Gemini facilities.
• Perform room clearance checks throughout manufacturing and packaging areas.
• Have basic familiarity with equipment used in the manufacturing and packaging of pharmaceuticals.
• Perform room clearance checks of manufacturing and packaging rooms as applicable.
• Perform daily inspection checks to pest control stations.
• Perform daily scale checks.
• Ensure product quality through visual inspection of goods in accordance with the ANSI/AQL sampling standard and requirements to determine a final disposition of finished bulk and/or packaging components.
• Should be able to wear a filtering facepiece (dust mask, surgical mask, respirator) throughout the day.
• Conduct Special Projects and/or perform other functions as instructed by Quality Assurance Management.

Pharmacy

• Ensure raw materials are received, sampled, and status controlled per procedure.
• Monitor Sampling and Pharmacy operations.
• Creation of raw material inventory cards upon QC release of materials.

Manufacturing

• Perform manufacturing checks of raw materials, product blends, and capsule shells at setup as well as throughout manufacturing runs.
• Perform manufacturing checks during the compression process, limited to weight, hardness, thickness, and physical appearance checks.
• Perform manufacturing checks during the encapsulation process, including but not limited to weight checks and physical appearance checks.
• Perform manufacturing checks during the coating process.
• Pull test samples for the Quality Control Laboratory
• Perform process checks during the bulk inspection process.

Packaging

• Perform verification of packaging components at the line set-up as well as throughout the packaging run.
• Perform verification of packaging components at the line set-up as well as throughout the packaging run.
• Perform labels and carton confirmation checks at start-up as well as during packaging runs.
• Perform half-hour checks on products during the packaging process, including but not limited to: Label checks, cotton checks, barcode checks, product count, product name, proper seal, etc.
• Perform clean room checks every hour to ensure there are no pills on the floor, no extraneous packing debris, or spillage.
• Pull Packaging retain samples.

Receiving

• Sampling, Inspection, and Release of Component Materials; status monitoring of components
• Review packaging component inventory forms for accuracy and completion; resolve inventory discrepancies; approve and close out forms.
• Perform in-process inspection checks in the inspection department.

KPIs/Reporting

Skills and Experience required

Education: High school education (graduate or GED preferred); or up to 4 plus years of related experience or training; or equivalent combination of education and experience.

Language Ability: Strong communication skills, both verbal and written (Report Writing) (Data Analysis)

Some knowledge of Spanish is helpful.

Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Mechanical Measurement required

Supervisory Responsibilities: None.

Environment

Work Environment: This role involves exposure to moving mechanical parts and moderate noise levels. Strict safety compliance is essential, including adherence to safety rules and prompt accident reporting. Reasonable accommodation is available for individuals with disabilities.

Physical Demands: This position requires regular standing, manual handling, reaching, speaking, hearing, and smelling. Frequent walking, stooping, kneeling, twisting, and crouching are expected. Responsibilities include pushing and pulling carts, lifting up to 20 pounds individually, and team-lifting up to 70 pounds. Visual requirements include close, distance, and depth perception.